A phase 3 trial found different doses of abrocitinib demonstrated efficacy as a treatment for atopic dermatitis.
Abrocitinib (PF-04965842, Pfizer), a Janus kinase 1 (JAK1) inhibitor, is a once-daily, oral treatment for moderate to severe atopic dermatitis (AD) in patients 12 years and older. Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center, Portland, Oregon, presented the results of the JADE REGIMEN trial (NCT03627767) at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX).1
The purpose of this study was to measure flaring in patients when taking abrocitinib long term.
In the study, patients were given abrocitinib for 12 weeks and then randomized into 3 treatment arms for the duration of Week 12 through Week 50. The treatment arms are as followed: placebo, abrocitinib 100 mg, and abrocitinib 200 mg.
Study enrollment requirements consisted of patients to be 12 years or older, have AD for 1 year or longer, a body surface area (BSA) score ≥ 10%, Eczema Area and Severity Index (EASI) scores ≥ 16%, and an Investigator Global Assessment (IGA) score ≥ 3.
“These are the typical type of atopic dermatitis patients we have been seeing in recent years,” said Blauvelt.
Out of the 1,733 patients screened, 1,233 were enrolled and 798 were randomized. Based on the IGA scores of the patients, about 60% had moderate AD and 40% had severe AD while the average EASI score was 30.
After the first 12 weeks, 65.2% of patients achieved IGA 0/1 and EASI 75. Patients had to meet both of these requirements to be a responder.
The primary endpoint of the study was a proportion of patients entering rescue during the maintenance period due to protocol-defined flare. To be considered a flare, the patient needed to demonstrate a EASI 50 loss and a IGA score of 2 or higher.
In the placebo group, 81% of patients flared, most by Day 29. The abrocitinib100 mg group had 42.6% of patients flare versus 18.9% of the 200 mg group up to Week 40.
Patients who had flare ups and were not in the high dose group were treated with 200 mg of abrocitinib. Those who were in the high dose group were then treated with an additional topical corticosteroid (TCS). More than 90% of placebo patients recovered EASI 75 versus 74.5% of the low dose abrocitinib patients and 55% of high dose abrocitinib patients.
“As far as side effects, there are a number of things listed,” Blauvelt said. “We saw a little more nausea, a little more CPK [blood creatine phosphokinase], and a little bit more acne in the 200 mg group compared to the 100 mg group compared to the placebo.”
Nausea, CPK and acne were adverse events (AEs) that were affected by dose, according to Blauvelt. All AEs were under 10% for patients affected.
Also, there was about a 35% decrease in platelet levels during the first 12 weeks of the abrocitinib study. However, these returned to baseline after continued treatment.
“We now have data on dose flexibility on abrocitinib in your patients with moderate to severe atopic dermatitis,” Blauvelt concluded.
Blauvelt has served as a scientific adviser and/or clinical study investigator for Pfizer, AbbVie, Abcentra Aligos, Almirall, Amgen, Arcutis, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Landos, LEO, Novartix, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma.
1. Blauvelt A. Abrocitinib Induction, Randomized Withdrawal and Response Recapture With Rescue Therapy in Patients With Moderate to Severe Atopic Dermatitis: Results From the Jade Regimen Phase 3 Trial. Presented at the: American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX); Virtual.